Objectives: This open label, phase I clinical trial (NCT02945462) using 2 consecutive intracavernous autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) for the first time in the treatment of diabetic patients with erectile dysfunction (ED). The primary outcome is to assess the safety and tolerability of intracavernous autologous BM-MSCs, the secondary outcome is to assess efficacy of the procedure. Patients and Methods: Four diabetic patients with refractory ED were included. Two consecutive intracavernous autologous BM-MSC injections were performed. Tolerability was assessed immediately and at 24 h, safety was evaluated for 2 years. Efficacy was assessed using International Index of Erectile Function-15 (IIEF-15) and Erection Hardness Score (EHS) for 12 months. Results: procedure was well tolerated and no patients reported significant adverse effects. There was significant improvement of IIEF-15 and EHS; IIEF-15 (p = 0.04), Erectile Function (p = 0.03), Sexual Desire (p = 0.04), Intercourse Satisfaction (p = 0.04), and Overall Satisfaction (p = 0.04). Conclusion: This is the first human study with proven tolerability, safety and efficacy of intracavernous autologous BM-MSC injections for treatment of diabetic patients with ED.
Background and Objectives: Stem cell therapy is a novel treatment with regenerative ability that can treat erectile dysfunction (ED). This phase 1/2 clinical trial (NCT02945449) using 2 consecutive intracavernous (IC) injections of allogeneic Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) was studied for the first time in the treatment of diabetic patients with ED. The primary outcome was to assess the safety and tolerability, and the secondary outcome was to assess the efficacy of 2 consecutive IC injections of allogeneic WJ-MSCs in diabetic ED. Patients and Methods: Twenty-two diabetic patients with refractory ED were included. Two consecutive IC injections of allogeneic WJ-MSCs were performed. Tolerability was assessed immediately, and at 24 h, safety was evaluated for 12 months. Efficacy was assessed using International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS), and Color Duplex Doppler Ultrasound for 12 months. Results: The procedure was well-tolerated. Minimal and transient adverse events were redness and bruising at the site of injections. There were no patient-reported serious adverse effects. There were significant improvements in IIEF-5, EHS, peak systolic velocity (PSV) basal, and 20-min PSV, all over the follow-up time points in comparison to the baseline. Conclusion: This is the first human study with proven tolerability, safety, and efficacy of IC injections of allogeneic WJ-MSCs for the treatment of diabetic patients with ED.
1 April 2019 in International Journal of General Medicine
Background: Medical research involving humans is now common all over the world. Medical doctors and residents are increasingly involved in such research. As part of their training requirements, medical residents in many institutions have to be involved, to different degrees, in human research projects. Methods: In this study, knowledge, awareness, and attitudes of resident doctors toward research ethics committees (REC) and informed consent (IC) processes were evaluated. For that purpose, a sample of 209 medical residents of different years from a major teaching hospital was surveyed. Results: Results showed that resident doctors had minimal knowledge of major ethical guidelines such as the Declaration of Helsinki and Belmont Report. However, more than half of respondents in this study had general knowledge of REC. Additionally, the majority of participants believed that there is a need for REC in each research conducting institution, and that training is also needed for REC members. Moreover, 82.7% of participants thought that investigators should have some training in research ethics. Finally, the current study showed that 60.3%–88.7% of participants were aware of IC requirements in clinical research. Conclusion: Although many residents showed good knowledge and positive attitudes regarding certain aspects related to REC and IC, others need improvement.
Most acute respiratory infections (ARIs) in children are due to viral etiology; however, over-prescribing of antibiotics for ARIs is common. The aim of this investigation was to identify antibiotic prescribing prevalence for children with ARIs and to identify predictors of broad-spectrum antibiotic prescribing. This was a prospective cross sectional study in a sample of ambulatory care settings in Jordan. Children (<18 years) presenting with ARIs were assessed in terms of patient's demographics, antibiotic prescription and clinical diagnosis. Multivariable logistic regression analysis was used to identify predictors of broad-spectrum antibiotic prescription. Antibiotics were prescribed for 78.4% (4575/5829) of children with ARIs. Antibiotic prescription for ARIs for which antibiotics are not indicated was 69.2% (2688/3883). Broad-spectrum antibiotic prescription occurred in 51.1% (2337/4575) of all antibiotic-prescribed participants. Some of the predictors of broad-spectrum antibiotic prescription were: otitis media (OR 4.93 [95% CI 3.44–7.14]), tonsillitis (OR 6.03 [95% CI 4.39–8.33]), age 0–5 years (OR 1.17 [95% CI 1.02–1.38]) compared to age 6–12 years, fever (OR 2.14 [95% CI 1.78–2.59]), outpatient setting (OR 73 [95% CI 2.17–3.42]) and military sector (OR 2.29 [95% CI 1.82–2.90]). Antibiotic prescribing is high and often inappropriate. Predictors of broad-spectrum antibiotic prescribing were identified. Health policy initiatives should involve all stakeholders to minimize inappropriate antibiotic prescription and to prevent poor outcomes associated with such practice.
1 January 2021 in International Journal of General Medicine
Background and Objectives: Coronavirus disease-2019 (COVID-19) is an emerging disease threatening the world with a rapid increase in cases and deaths since it was first identified in December 2019. Adequate knowledge, practice, and attitudes (KPA) toward COVID-19 among physicians at the frontline defense against the COVID-19 pandemic may enhance their ability to avoid the risk of self-infection, decrease mortality, and provide adequate medical care service in this pandemic. This study aimed to assess KPA toward COVID-19 among physicians in Jordan and Palestine. Methods: This is a cross-sectional study using an online survey conducted from 10 April to 26 April 2020 among Jordan and Palestine physicians. Invitations were sent to physician groups on Facebook and WhatsApp. This survey contains 36-items, divided into four main sections to assess the participants’ socio-demographic characteristics, knowledge, practice, and attitude about COVID-19. Results: A total of 454 physicians participated in this study. The mean score of basic knowledge was 4.4 ± 0.8 (range 2– 4). There were significant differences between basic knowledge mean scores among physicians in different professional degrees and physicians in various health sectors (P=0.0315, P=0.0137, respectively). The mean scores of self-protection measures, were 6.1 ± 1.1 (range 3– 7) and measures if physician self-suspected of COVID-19 were 9.9± 1.1 (range 5– 11). The mean score of attitudes toward COVID-19 was 41.5 ± 3.3 (range 21– 45) and significantly related to the age and different experience years (P=0.0022, P=0.0077, respectively). Conclusion: As the global threat of COVID-19 continues to emerge, physicians from Jordan and Palestine showed adequate KPA toward COVID-19. There was a significant difference in knowledge level and attitude between physicians. Policymakers and physicians should keep continuous educational activities, training, and follow-up updates during this pandemic.
Recurrent urinary tract infections (UTI) are a major source of morbidity and healthcare costs. Risk factors associated with recurrence rates in premenopausal women can be attributed to patient lifestyle behavior. The aim of this study was to assess hygienic risk factors, determine pathogen distribution, and susceptibility patterns in premenopausal women with recurrent UTI. This was case-control study in which a face-to-face interview was conducted to obtain information from premenopausal women with recurrent UTI. Microbiology cultures and susceptibility results were obtained to analyze pathogen distribution and resistance. In this study, 214 cases and 230 controls were compared and the following practices were associated with increased risk of recurrent UTI in multivariable analysis: washing genitals from back to front (OR 1.64 [95% CI 1.05–2.56]), not voiding within 15 min after intercourse (OR 2.81 [95% CI 1.72–4.66]), not drinking water after intercourse (OR 1.69 [95% CI 1.12–2.58]), using any soap to clean after urination (OR 2.11 [95% CI 1.42–3.17]). Escherichia coli were the most prevalent pathogens isolated (66.4%), followed by Klebsiella spp. (12.6%), Pseudomonas aeruginosa (12.1%), and Proteus spp., (6.6%). This study identified several modifiable sexual and hygienic practices associated with recurrent UTI in premenopausal women. Continuous surveillance of antimicrobial susceptibility patterns is important to overcome resistance.